CLINICAL RESEARCH SUPPORT SERVICES: A central mission of the OCD is to ensure that research participants receive the highest quality clinical care. The OCD is responsible for oversight of all clinical aspects of the NIMH Intramural Research Program (NIMH IRP). HUMAN SUBJECT PROTECTIONS: The mission of the Human Subject Protections Unit (HSPU) is to ensure the protection of vulnerable subjects participating in research and to educate researchers and participants. This team works with investigators, the Institutional Review Board (IRB), and the Clinical Center (CC) Bioethics Department to identify and ameliorate risks for vulnerable subjects. Responsibilities include: 1) Consent and Assent Monitoring which assesses the quality of the informed consent process and ensures that all of the required elements of the protocol are discussed with participants. Assent monitoring ensures the quality of the assent discussion and verifies the agreement of the subject to participate in research. 2) Subject Monitoring of all NIMH inpatients verifies ongoing informed consent over the course of their participation in research. 3) Capacity Assessment is a clinical assessment of an adult participant's ability to provide informed consent for a specific protocol. For select high-risk studies, a capacity assessment must be completed prior to study participation. 4) Ability to Appoint an NIH Advanced Directive/Durable Power of Attorney (DPA) Assessment determines a participant's ability to choose another person to be his/her decision-maker for research participation. 5) Appropriateness of the Surrogate Assessment determines the appointed surrogate decision-maker's ability to represent a participant's wishes and provide consent. 6) Training and Education: The HSPU developed and conducts the Elements of a Successful Consent, a required training for investigators obtaining informed consent. To date, over 1500 NIH staff have completed this training, also available as a computer-based training program. In response to inquiries from other institutions, the HSPU has developed a toolkit to assist research organizations to assess, develop and implement appropriate levels of human subjects protections at their own facilities which will be publically launched this fall. CLINICAL OVERSIGHT: The OCD team meets regularly with NIH Clinical Center (CC) medical and nursing leadership to review CC census (Outpatient census has increased 32% over the same period last year), discuss clinical concerns and plan for future initiatives. The monthly PSQ meeting is also a forum for communication of hospital-related policies and regulations and includes quality improvement projects from each branch/section. The OCD team has coordinated the hospital-wide implementation of suicide risk screening at the CC in response to a Joint Commission Sentinel Event Alert 56 calling for suicide risk screening of all medical patients in the hospital setting (see ZIA MH002922-11). The OCD is responsible for credentialing through reviewing the qualifications of all clinical personnel and is involved in maintaining the clinical competence of all NIMH health care professionals. As the link between the CC hospital and the Institute, the OCD is responsible for the implementation of CC policies and standard operating procedures (SOPs). The OCD participates in annual CC budget planning meetings with the CC and IC Directors and coordinates hospital initiatives such as preparation for Joint Commission accreditation visits, annual flu shot compliance, etc. PATIENT SAFETY AND QUALITY (PSQ): In 2016, the OCD established the Office of Patient Safety and Quality. The Clinical Director, along with other OCD staff, oversees NIMH quality improvement initiatives and meets with each branch/section/lab chief and manager to assist with designing patient safety and quality improvement initiatives, with a dual focus of improving and ensuring quality clinical care, and sharing their experiences with the larger NIMH intramural clinical care group during monthly PSQ meetings. The OCD also tracks and trends Clinical Center occurrences and ensures follow-up. The OCD sends representatives to Clinical Center safety and quality initiatives, including daily patient safety huddles, the hospital-wide Clinical Care and Quality meeting, and the Patient Safety Clinical Practice and Quality Committee. NIMH monthly safety meetings for basic science labs are also attended by an OCD representative. Each branch/lab/section has presented at least one PSQ project and is now being scheduled to present follow up findings for their ongoing continuous quality improvement projects. The OCD PSQ team has also established a method for recredentialing medical staff using the Medical Re-Credentialing Evaluation (MRCE) that allows medical staff to self-evaluate and select peers for evaluations as well. The MRCE project has served as model for the Clinical Center leadership who is adopting a similar program to be implemented hospital-wide. SCIENTIFIC REVIEW: The Committee for Scientific Review of Protocols (CSRP) reviews all new clinical protocols. A subcommittee conducts annual review of ongoing protocols. REGULATORY OVERSIGHT: The Office for Regulatory Oversight (ORO) focuses on compliance with regulatory requirements and Good Clinical Practice (GCP). The NIMH Clinical Director now serves as the IND/IDE sponsor with support from ORSC. This office coordinates the scientific review of new and ongoing protocols and provides protocol navigation services to investigators. The navigation team provides direct support to investigators for all aspects of IRB submissions and tracking of investigator trainings. The OCD has implemented genetic data sharing and data sharing plans for intramural studies in accordance with NIH policy. The OCD coordinates a Data and Safety Monitoring Board (DSMB) to oversee DIRP protocols. Two clinical monitors develop and implement individualized monitoring plans for all active NIMH IRP protocols. This team also provides training and develops corrective action plans as needed. TRAINING AND EDUCATION: The NIMH OCD works in partnership with the NIMH Office of Fellowship Training (OFT) and the Office of Clinical Research and Training in Medical Education (OCRTME) to oversee and participate in several programs that train and educate new physicians and medical students. In addition, the NIMH OCD contributes to initiatives that identify and promote academic research careers among promising early career psychiatrists. See OCD Training report ZIEMH002939-06 for details. CONSULTATION LIAISON: The NIMH Psychiatry Consultation Liaison Service (PCLS) and Neuropsychology Consultation Service are teams that provide multidisciplinary clinical services to patients enrolled in clinical protocols at the NIH CC. Two additional clinical services were added in 2017, the Neurodevelopmental and Behavioral Phenotyping Service (see Dr. Thurm's report ZIC-MH002961-03) and the Sleep and Neurodevelopment Service (see Dr. Buckley's report ZIC-MH002962-03). See OCD Psychiatry Consultation Liaison Service Research ZIA-MH002922-11 for additional details. The MARKETING COMMUNICATIONS AND RECRUITMENT UNIT (MCRU) facilitates comprehensive, creative and diverse NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. In FY18, our Community Outreach Program reached over 38,000 individuals through over 187 meetings with providers, consumers, community members, 34 scientific seminars, and electronic mailings. MCRU provides website support and liaisons with the Office of Science Policy, Planning and Communications.